1. Field of the Invention
The present invention relates generally to the field of nutritional and dietary supplements and pharmaceutical products, and more particularly this invention relates to an improved release process for vitamins, active pharmaceutical products, flavoring systems, sweeteners and mineral supplements from a chewing gum-type carrying agent. Thus, the invention is in the field of improved release of flavor and nutritional elements from a chewable carrier or applicator composition over a controlled period. More particularly the present inventor provides an improved release system for vitamins and other health effecting elements for chewing gum-type applicator systems and the like.
2. Preliminary Discussion
Pharmaceutical and nutritional supplement dosage agents intended for oral administration are typically provided in solid form as tablets, capsules of various types, lozenges or so-called caplets or capsules. Tablets can be swallowed whole, usually with water, chewed in the mouth and then swallowed or sometimes applied sublingually, i.e. dissolved in the mouth, usually under the tongue. Absorption of the active moiety in the tablet depends upon its release from the dosage form, usually in a solid form, which may be controlled by various different technologies.
Since many consumers either dislike “taking pills” or may well forget to take them, attempts to encourage regular self-administration have been made by adding flavor elements to the pills or capsules.
More recently, the dosage of vitamin supplement elements and other pharmacological elements have been administered in the form of chewing gum. This has the advantage that the one taking the dosage will be more likely to take such dosage regularly and assuming they like to chew gum, or can be habituated to like it, will commonly take it regularly rather than regularly forgetting to take it. In addition, in the absence of a readily available water supply one can still take their vitamins or other supplemental nutritional elements or other medicine in the form of gum. while in pill form water is almost always required in order to aid in swallowing the supplement pill or in washing a chewed pill into the gastrointestinal tract.
It has been suggested previously, therefore, to provide dosages of supplemental vitamins of various kinds, as well as pharmacological elements such as nicotine, caffeine and other mild and unlikely to be abused pharmaceutical agents from chewable release agents such as chewing gum and the like together with flavor agents which encourage the user to continue chewing for the time necessary to obtain the desired dosage of the vitamins or other desired element.
Unfortunately, in such gum-type release systems, while there is an initial heavy release or flush of the substance desired to be released into the bucal and sublingual cavity, such release quickly declines or “drops off” so that the desired release substance such as a vitamin content and/or pharmaceutical content quickly declines along with the release of flavor content. While the rapid drop off or release of flavor or flavoring agent is not necessarily, at least in the eyes of many manufacturers, an undesirable effect, since it encourages the consumer of the chewing gum to discard the partially chewed gum and hopefully to take another or fresh piece of chewing gum, as a practical matter tests have shown that as much as 80 to 85% of any vitamins or other pharmaceutical elements remains in the gum element when it is discarded. Consequently, in a gum which advertises that it contains, for example, 200 units of vitamin B complex, 160 of such units will usually remain in the gum when such gum is discarded and as a result, the consumer is not provided with anywhere near, or anywhere like, the amount of vitamin content or other pharmaceutical contents which they believe they are receiving. This is not only a detriment to the consumer, but an unnecessary cost to the producer of the chewing gum release system or dosage system. Furthermore, assuming that the chewer is attempting to achieve a given dose of vitamins or other pharmaceutical unit, it is clearly necessary that they obtain most of the available content from each piece of gum chewed, since if the chewer believes they have to chew more gum to obtain the desired dosage, or aimed for dosage, they will have to chew more gum and may merely achieve an undesirable result.
Since many or, even most gum chewers will tend to throw away their gum and take another piece when the flavor element becomes exhausted, it is also desirable if the flavor element is substantially exhausted at the same time or at least not before the vitamin or pharmaceutical content is exhausted. It is also naturally desirable, so far as a manufacturer or vendor of the gum delivered pharmaceutical or supplement product is concerned, if the flavor element or enhancer does not last too long so that any given piece of product is not chewed too long in order to encourage the exchange for a new piece.
A fairly new gum technology, namely so-called compressed gum, has been commercialized in the last several years. Traditional gum has been made by essentially mixing together a viscoelastic component with any other desired ingredients such as flavor elements and the like including supplemental vitamins and/or pharmaceutical elements such as nicotine alkaloids and the like, with the mixing being conducted usually in steam jacketed mixers somewhat similar to large kitchen mixers and bowls or similar apparatuses. Because such mixing tends inherently to be uneven, or streaky, very similar to the mixing of cake or bread dough, such mixing has been at best uneven and in fact when such gums are chewed, additional mixing occurs in the mouth; but even then the flavor, pharmaceutical and buffering components are at best only partially mixed. This is satisfactory for some uses, but when one wishes the ingredients to be precisely released has been found to be less than satisfactory. Thus when the sticky gum material is extruded after initial mixing into usually a flat sheet which is then usually severed into thin strips which are then in turn severed into square or oblong sections of gum and forthwith wrapped, not only is the equipment covered with a sticky goo which requires a great deal of labor to clean and keep clean, but the mixing of ingredients in the gum is uneven at best and each piece, or stick, of gum varies considerably in the amount and distribution of any ingredients mixed into the gum or any portion of the gum. As a result, the coordination of a mixture of ingredients mixed together in the gum is invariably not very satisfactory.
The present inventor has found that by the use of the more recently commercially available technology of so-called compressed gum in which the gum components are initially formed into fine particles or particulates of powder which fine particles are then compressed by a tablet press into individual gum pieces of any desired shape or size that a much more satisfactory release system can be attained because the manufacturing process can be adapted to provide a much more intimate and accurate mixture of ingredients to provide a relatively accurate and uniform mix of ingredients in any particular gum particulate. The present inventor has also found that with the use of a precisely calculated amount of sweetening elements, nutritional supplement and/or pharmaceutical elements and buffing elements or substances all initially mixed together as fine particles or particulates together with the powdered gum particles or particulates and compressed together in a uniform larger particulate mass and then compressed into a final pellet or gum particle for consumption, a gum product can be and is produced which upon mastication in the mouth cavity will release both its nutritional supplement and/or pharmacological values at a precisely calculated rate usually designed to completely release both sweetening and nutritional and/or pharmaceutical moieties in a period of up to 30 minutes of mastication depending upon what is desired, or longer if desired, so that almost the full load of supplementary nutrition elements, or vitamins, are released during chewing or mastication followed immediately by a precipitous drop off of the sweetener released so that the average user will discard that particular piece of gum and select another piece. The individual component particles of the gum, flavor and nutritional and/or pharmacological elements are provided in a granulation fineness which will largely prevent any but very slight undesired reaction between them as long as kept dry to provide a desirable shelf life of several years, but will be finely enough divided so that an immediate release of such elements will occur in the bucal or mouth cavity upon mastication and exposure as a result of such mastication to moisture from the saliva of the mouth.
One characteristic of compressed gum that has proven unpopular with consumers is a tendency to feel that the gum is crumbling in the chewer's mouth until it has been significantly masticated, at which time it reverts to the feeling of typical gum. This feeling is caused by the fact that the gum particulates which are largely surrounded by other ingredients are in fact largely mechanically adhered by the pressure of the pelletizing process and because surrounded by other ingredients, initially break apart upon the beginning of mastication in the bucal cavity.
While such incipient crumbling is a benefit to expression or release of the other values for the gum, such as nutrients and pharmacological agents, its unfamiliar feeling of lack of consistency may be disconcerting to users of the gum products. Furthermore, crumbling will cause up to as much or more of the flavor and dietary supplement values to be almost immediately released followed by a tapering off period. The present inventor has found by extensive testing, however, that the use of a plasticiser during the manufacture of the final dose of compressed gum will alleviate the feeling of crumbling without seriously interfering with the expression of the nutritive content or pharmaceutical content of the compressed gum. Furthermore, the prevention of crumbling slows down the initial flush or release of ingredients and allows more exact control of simultaneous release of both the flavor and nutritive and pharmaceutical values by the proper use of buffers.
In order to have a proper effect, the plasticiser should be added to the formulation before a glidant material, i.e. silicon dioxide and lubricant are entered into or mixed into the formulation. By use of the plasticiser ingredient, the initial adherence of the gum particulates is increased and their breaking apart is delayed beyond the usual 30 seconds or so when the usual crumbling effect is noticeable after which the gum particulates are further driven together by the mastication itself. On the other hand, the release of the nutritional and/or pharmaceutical values are not substantially interfered with and less overall of such materials are necessary because they are not so much trapped in the gum, but completely expressed by proper buffering.
In order to obtain the desirable results of the invention, the present inventor has discovered that it is necessary to carefully balance the size and the amount of gum particles or particulates, flavor elements and release as well as buffering elements to obtain the desired simultaneous release of and ultimate exhaustion of flavor compounds, nutritional supplement compounds or elements and/or pharmacological compounds and release or buffering compound or compounds as well as plasticiser elements to provide the desired results and without such careful and critical combination the simultaneous release will not be obtained. By the broad term, nutritive values the invention includes not only various vitamin, agents, but also mineral nutritive agents, such as calcium, iron, zinc and the like.
Preferably non-nutritive sweetener compounds such as Xylitol, which is an alcohol rather than a sugar and does not normally support major bacterial activity in the mouth, is mixed in lesser amounts with aspartame and Ace-K which also do not readily support bacterial growth such as is found in the mouth or bucal cavity. At the same time, the buffering agents sodium carbonate and sodium bicarbonate are used in critical quantities and particular sizes to regulate the release of the flavor agents and supplemental nutritive values as well as any pharmacological values. Other release or buffering value agents could also be used such as magnesium stearate, potassium carbonate and citric acid can also have beneficial effects. None of these support bacterial activity and all but the citric acid tend to establish bucal cavity conditions that are not favorable to tooth decay.
3. Description of Related Art
British Patent 1,325,011 published Jul. 9, 1971 assigned to Aktiebolage Leo of Sweden contains a thorough discussion of the inclusion and release of so-called tobacco alkaloid or nicotine alkaloid from ordinary chewing gum. The disadvantage of too quick release is discussed and the use of ion exchange resin compositions and particularly cation exchangers designed to effect both retention and release of the nicotine alkaloid during chewing of the gum depending basically upon the acidity are discussed together with sweetening inclusions in the gum including both sugar based and sugarless based sweetening agents are discussed and the conditions for proper release of the nicotine alkaloid suggested. The release rate of the nicotine alkaloid from the gum composition is bound closely to the quantity of cation exchanger material, which is used, preferably in the hydrogen ionic form. Applicant's release system is not disclosed, however.
U.S. Pat. No. 5,637,313 issued Jun. 10, 1997 to Chau et al. discloses a method of making chewable dosage forms including the use of a gum base and various pharmaceutical agents and may include Xylitol, a sugarless sweetening agent in the form of an alcohol related to the sugar xylitose. A long list of possible inclusions is provided including modifiers, bulking agents and flavoring agents including calcium carbonate and the like. The applicant's particular composition, however, is not disclosed nor the applicant's method of making his product set forth.
U.S. Pat. No. 6,083,527 issued Jul. 4, 2000 to Thistle discloses the provision of a breath mint including particularly Xylitol as a natural sweetener buffered with calcium hydroxide to provide a confection to which vitamins may be added in dosage form. The simultaneous delivering of vitamins while preventing tooth decay because the ingredients do not encourage tooth decay is disclosed and the dosage vehicle is disclosed as including the use of a gum. Applicant's particular composition for attaining controlled release of both the flavoring and active ingredients is not disclosed, however.
U.S. Pat. No. 6,531,114 issued Mar. 11, 2003 to Gunder et al. assigned to the Wm. Wrigley, Jr. Company discloses the advantages of having a pharmacological sublingual or bucal route for certain pharmaceutical agents making absorption from a chewing gum vehicle particularly advantageous, but does not disclose the efficiency of compressed gum for gaining very immediate absorption in the mucus membranes of the bucal cavity.
U.S. Pat. No. 7,163,705 issued Jan. 16, 2007 to Johnson et al. and assigned to the Wm. Wrigley, Jr. Company thoroughly discusses the addition of various supplements and medicaments to the traditionally mixed gums with buffering systems comprised of sodium carbonate and sodium bicarbonate and includes a very large number of cited references. The use of compressed gum is not disclosed, however.
Rohm and Haas ion exchange product data sheet copyrighted in 2000 by Rohm and Haas Company provides a discussion of the use of Amberlite™ resin for controlled release of pharmacological units from compounds but does not disclose applicant's product or method of making.